Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Whole virion influenza vaccine, inactivated containing antigen of strain A/California/07/2009 (H1N1)v
Nanotherapeutics Bohumil, s.r.o.
J07BB01
influenza vaccine (H1N1)v (whole virion, Vero cell derived, inactivated)
Vaccines
Disease Outbreaks; Influenza, Human; Immunization
Prophylaxis of influenza caused by A(H1N1)v 2009 virus.Celvapan should be used in accordance with official guidance.
Revision: 11
Withdrawn
2009-03-04
24 B. PACKAGE LEAFLET Medicinal product no longer authorised 25 PACKAGE LEAFLET: INFORMATION FOR THE USER CELVAPAN SUSPENSION FOR INJECTION Influenza vaccine (H1N1)v (whole virion, Vero cell derived, inactivated) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU RECEIVE THIS VACCINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or nurse. - If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Celvapan is and what it is used for 2. What you need to know before you receive Celvapan 3. How Celvapan is given 4. Possible side effects 5. How to store Celvapan 6. Contents of the pack and other information 1. WHAT CELVAPAN IS AND WHAT IT IS USED FOR Celvapan is a vaccine to prevent influenza (flu) caused by A(H1N1)v 2009 virus When a person is given the vaccine, the immune system (the body’s natural defense system) will produce its own protection (antibodies) against the disease. None of the ingredients in the vaccine can cause flu. 2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE CELVAPAN YOU SHOULD NOT RECEIVE CELVAPAN: if you previously had a sudden life-threatening allergic reaction to any ingredient of Celvapan or to any of the substances that may be present in trace amounts as follows: formaldehyde, benzonase, sucrose. - Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue. If you are not sure, talk to your doctor or nurse before having this vaccine. TAKE SPECIAL CARE WITH CELVAPAN: Check with your doctor or nurse before you are given Celvapan if you have had any allergic reaction other than a sudden life-threatening allergic reaction to any ingredient contained in the vaccine, to formaldehyde, benzonase, or to sucrose. (see section 6. Further information). you have a severe infection with a high temperature (over 38 °C). I Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Celvapan suspension for injection Influenza vaccine (H1N1)v (whole virion, Vero cell derived, inactivated) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Whole virion influenza vaccine, inactivated containing antigen of strain *: A/California/07/2009 (H1N1)v 7.5 micrograms** per 0.5 ml dose * propagated in Vero cells (continuous cell line of mammalian origin) ** expressed in micrograms haemagglutinin. This is a multidose container. See section 6.5 for the number of doses per vial. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. The vaccine is a clear to opalescent, translucent suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prophylaxis of influenza caused by A(H1N1)v 2009 virus (See section 4.4). Celvapan should be used in accordance with Official Guidance 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ _ Posology The dose recommendations take into account available data from clinical studies in healthy subjects who received two doses of Celvapan (H1N1)v. From clinical studies limited immunogenicity and safety data are available for Celvapan (H1N1)v in healthy adult and older subjects and in children (see section 4.4, 4.8, and 5.1). Adults and older people One dose of 0.5 ml at an elected date. A second dose of vaccine should be given after an interval of at least three weeks. Children and adolescents aged 3 to 17 years One dose of 0.5 ml at an elected date. A second dose of vaccine should be given after an interval of at least three weeks. Children aged 6 to 35 months One dose of 0.5 ml at an elected date. A second dose of vaccine should be given after an interval of at least three weeks. Medicinal product no longer authorised 3 Children aged less than 6 months Vaccination is not currently recommended in this age group. For further information, see sections 4.8 and 5.1. It is recommended that subjects who receive a first dose of Celvapa Przeczytaj cały dokument